Vaginal or Laparoscopic Hysterectomy, Persistent Postsurgical Pain

Chronic Postsurgical Pain Clinical Trial

Official title:

Chronic Pain After Vaginal or Laparoscopic Hysterectomy for Benign Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537731
• Other study ID #: R08031M R09003
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: October 8, 2013
• Start date: April 2009
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Previous studies have shown that chronic pain after hysterectomy is common. The aim of this study is to investigate the incidence of chronic pain after vaginal or laparoscopic hysterectomy for benign reasons. The aim of this prospective study is also to study the role of anesthetics, surgery and other possible predictors for pain 6 months after hysterectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Patients who undergo vaginal or laparoscopic hysterectomy for benign conditions

• Age 18-69 years

• Gender: female

• ASA status 1-3

Exclusion Criteria:

• Body Mass Index over 35

• Diabetes mellitus

• Liver disease

• Preoperative use of opioids

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Postsurgical Pain

Intervention

Procedure:
• vaginal or laparoscopic hysterectomy
vaginal hysterectomy or laparoscopic hysterectomy

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of persistent postsurgical pain as measured at 6 months after surgery.		five years	No
Secondary	Severity, location, characteristics of persistent postsurgical pain.		five years	No
Secondary	Effect of postsurgical pain on activity, sleep.		five years	No